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OpenTrials
Completed

NCT Number: NCT05769101

Effects of a Recovery Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing

The investigation will be conducted as a double blinded, randomized, parallel between treatment conditions comparison design with two different groups ingesting a different supplement each one.

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Key information

Conditions

Protein Deficiency Atrophy Deficiency Diseases Fatigue Hypersensitivity Immune System Diseases Malnutrition Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Psychological Signs and Symptoms Training Group, Sensitivity

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT

London, Avery Hill, London., SE9 2BT, United Kingdom

About this study

Following inclusion, familiarization and baseline assessments, the participants will be randomly allocated to receive either a multi-ingredient, post-workout supplement (REC) or maltodextrin (CHO). Thereafter, the participants will follow a 6-weeks resistance training mesocycle, involving three resistance training sessions (Monday, Wednesday and Friday) per week (18 sessions in total). Before and after the 6 weeks of intervention, the following assessments will be performed: (i) Body composition (fat mass and fat-free mass) via air displacement plethysmography (BodPod); (ii) muscle contractile properties on Vastus Medialis and Anterior Deltoids (via Tensiomyography; (iii) muscle structure of the Vastus Lateralis of the Quadriceps and the Elbow Flexors of dominant extremities via Ultrasound; (iv) Maximal Isometric Strength (Isometric Mid-Thigh Pull); (v) Upper and Lower Body Muscular Power (Medicine Ball Throw and Vertical Jump), (vi) Upper and Lower Muscular Endurance (30- Seconds Sit-to-Stand and 30-Seconds 16RM Bench Press), (vii) Immune System (via HemoCue WBC DIFF System).

The supplements will be ingested immediately (within 15 min) after each training session.

Energy Feeling Questionnaire will be filled immediately before warming up.

In addition, Rate of Perceived Exertion to training will be assessed 15 min after the completion of all workouts.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy (no injuries, illnesses or medication intake).
  • Between 45 and 65 years old.
  • Active and familiarised with Resistance Training.

Exclusion criteria

  • Unhealthy (illnesses or medication intake) or injured.
  • Untrained.
  • Young (<45 y.o.) or elderly (>65 y.o.).

Treatment and study plan

Ingestion of a Post-Workout Supplement

Dietary Supplement

The Post-Workout Supplement is administered 15 minutes after the completion of training sessions. No supplementation is administered in non-training days. The Resistance Training is performed in alternate days. The training Protocol is: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Alternate Box Step-Ups, Bench Press; Parallel Squat; Up-right Row; Deadlift; Alternate Lunges; Shoulder Press; Leg Extension). The participants perform 16 repetitions of each exercise, with 30 seconds rest and 3 minutes rest after every set. If they can complete 16 repetitions easily, 2.5 to 5 kg are added for the next set. Also, whole-body Perceptual Response is assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.

Ingestion of a Maltodextrin Supplement

Dietary Supplement

The Maltodextrin Supplement is administered 15 minutes after the completion of training sessions. No supplementation is administered in non-training days. The Resistance Training is performed in alternate days. The training Protocol is: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Alternate Box Step-Ups, Bench Press; Parallel Squat; Up-right Row; Deadlift; Alternate Lunges; Shoulder Press; Leg Extension). The participants perform 16 repetitions of each exercise, with 30 seconds rest and 3 minutes rest after every set. If they can complete 16 repetitions easily, 2.5 to 5 kg are added for the next set. Also, whole-body Perceptual Response is assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.

Primary outcomes

  1. Vertical Jump

    Time frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

    Height (measured in centimetres)

  2. Chest Medicine Ball Throw

    Time frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

    Distance (measured in centimetres)

  3. Muscle Thickness

    Time frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

    Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs

  4. Self Perceived Energy Feeling

    Time frame: [Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program]

    All participants will fill a short questionnaire (from 1 to 5 points) about their perception of energy before every training. Energy Feeling will be assessed (Evergy level, Fatigue Level, Feeling of Alertness, and Feeling of Focus for the task, valued from 1 = low energy to 5 = high energy).

  5. White Blood Cells count

    Time frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

    White blood cell (WBC) count including a five-part differential

Sponsors and collaborators

Lead sponsor

Joel Puente

Other

Collaborators

  • Crown Sport Nutrition
  • Go Fit Spain

Registry information

Official study title

Effects of a Protein-Based Multi-Ingredient Recovery Supplement Combined With Resistance Training on Body Composition, Performance, Muscular Properties, and Wellbeing on Middle-Aged and Older Adults.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2023
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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